New Head of Federal Office Clear on Protecting Human Research Participants
Article Abstract:
The new director of the Office of Human Research Protection met with other scientists to discuss financial conflicts of interest in medical research. The meeting was called after it was discovered that a researcher participating in a gene therapy trial that killed Jesse Gelsinger owned stock in the company that sponsored the trial.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2000
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Bioethics advisory commission holds first meeting to define governing principles of ethical research
Article Abstract:
The National Bioethics Advisory Commission met in Oct 1996, one year after it was created by Pres Clinton. Its two major mandates are to review current procedures covering humans who are used as subjects in medical research and the ethical aspects of genetic testing. An additional topic of discussion will be the deficiencies in the institutional review board (IRB) system. Policies are needed to cover research on those who cannot give informed consent, such as children or the mentally ill. Laws and regulations cannot replace a responsible attitude among researchers.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1996
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Assessment of exception to informed consent
Article Abstract:
The FDA held a meeting in 1997 to evaluate the exception to informed consent regulation. This regulation, implemented in 1996, allows medical researchers to treat patients in emergency situations with investigational treatments without getting their immediate consent. This is important because the patient may be unconscious and unable to consent. However, the researchers are required to disseminate information about the study in the community, especially among those most likely to be affected. They must also try to find a family member or relative who can give consent within a reasonable amount of time.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1997
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